After releasing a proposed rule in April 2023, the Office of the National Coordinator for Health Information Technology (ONC) issued the final Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Rule on December 13, 2023.
As part of the Department of Health and Human Services (HHS), ONC is the “principal federal agency charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of information.” The Final Rule seeks to advance these goals by making updates to its Health IT Certification Program, providing a new version of the United States Core Data for Interoperability (USCDI) and updating information blocking regulations to provide greater support for information sharing.
Of special note are the algorithm transparency requirements for artificial intelligence (AI) and other predictive algorithms that are part of certified health IT, which according to HHS will “promote responsible AI and make it possible for clinical users to access a consistent baseline set of information about the algorithms they use to support their decision making.”
THE DECISION SUPPORT INTERVENTIONS CERTIFICATION CRITERION
Decision support tools in healthcare by clinicians, payers, researchers, and others increasingly utilize machine learning, and as to such tools the Final Rule has adopted the “Decision Support Interventions (DSI)” certification criterion.
With the stated objective of improving trustworthiness and supporting consistency surrounding the use of predictive algorithms or models in healthcare, according to ONC’s relevant Overview Fact Sheet, the criterion includes “new technical capabilities and transparency requirements for Health IT modules.”
More specifically, it addresses contemporary functionalities, configuration requirements and includes an “expanded set of information” related to evidence-based DSIs and Predictive DSIs.
The Final Rule also defines Predictive DSI as “technology that supports decision-making based on algorithms or models that derive relationships from training data and then produce an output that results in prediction, classification, recommendation, evaluation or analysis.”
As to health IT developers, according to the ONC Fact Sheet on DSIs, the Final Rule provides “clearer more precisely scoped” requirements, and states that they will only be responsible for the Predictive DSIs they supply as part of their certified Health IT.
It also calls for them to update health IT currently certified to the outgoing CDS criterion to meet the DSI criterion’s requirements and then make the updated certified health IT available to their customers by December 31, 2024.
Beginning January 1, 2025, developers that have health IT certified to the DSI criterion must also comply with additional maintenance of certification requirements.
INSIGHTS CONDITION
As part of the ONC Health IT Certification Program, the final rule created the Insights Condition and Maintenance of Certification (“Insights Condition”) in order to provide transparent reporting on certified health IT, with a focus that includes but is not limited to the following categories:
- interoperability;
- usability and user-centered design;
- security; and
- conformance to certification testing
According to ONC’s Fact Sheet on Insights Conditions, the objectives of the reporting are to address information gaps in the health IT marketplace; provide insights on the use of specific certified health IT functionalities; and to provide information about the use of certified functionalities by end users.
Accordingly, health IT developers participating in the ONC Health IT Certification Program are now required to submit responses annually via web-based method using templates provided by ONC that will allow for data to be in a structured, electronic format.
ONC also states that the required measures and metrics will be “phased in over three years,” according to a schedule it provides in the above Fact Sheet.
In order to not “unduly disadvantage small and startup developers of certified health IT,” health IT developers participating in the ONC Health IT Certification Program will only be required to report responses if the developer meets each of the following criteria:
1) The developer has at least 50 hospital sites or 500 individual clinician users across their certified health IT
2) The developer has health IT certified to the certification criteria specified in each measure; and
3) The developer has any users using the certified health IT associated with the measure.
The Final Rule’s Insights Condition Measures include seven measures across four areas related to interoperability with the areas consisting of individual’s access to electronic health information (EHI); Public health information exchange; Clinical care information exchange; and standards adoption and conformance.
The seven measures along with more specific information on the Insights Condition, including the reporting schedule mentioned above, are provided in ONC’s HTI-1 Fact Sheet on Insights Conditions as well as the text of the Final Rule.
INFORMATION SHARING
As stated in the ONC General Overview Fact Sheet for the Final Rule, enhancements have been provided to “support information sharing.” This has been done in the form of updates to the information blocking regulations that are of a technical nature and are “in response to feedback from affected parties.”
Among such updates, the definitions of “offer health IT,” “health IT developer of certified health IT,” and “information blocking,” were either added or revised under the Final Rule as follows:
- To “offer health IT” with regards to information blocking will generally include “proffering or supplying any certified health IT to be deployed by others,” but the definition has been narrowed from what it previously was;
- A “health IT developer of certified health IT” does not include a health care provider that self-develops certified health IT, so long as the provider does not “offer” any certified health IT; and,
- USCDI v1 related elements (that were applicable before October 6, 2022) were removed from the definition of “information blocking.”
Exceptions
According to the HTI-1 Information Blocking Fact Sheet, exceptions are “voluntary and provide assurances to actors that, when a practice meets the exception, it will not constitute information blocking.”
The Final Rule revises the infeasibility exception so that the “uncontrollable events” condition provides more clarity when an actor’s practice meets this condition. Additionally, a new “third party seeking modification use” condition has been added, along with a “manner exception exhausted” condition.
The prior “Content and Manner Exception” has also been changed to the “Manner Exception,” as the “content” condition is no longer applicable.
Finally, the new “TEFCA Manner” Exception applies when both the actor and the requestor are part of TEFCA.
Categories: AI, DATA ACCESS & INTEROPERABILITY
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